SYMLIN (pramlintide acetate) injection for subcutaneous use 4 SymlinPen (SĬM-lĭnPen) 120 (pramlintide acetate) Pen-Injector Read the Medication Guide and these Instructions for Use before you start using SYMLIN and each time you get a refill. There may be new information. Do not share your SymlinPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Important: Ask your healthcare provider about your dose of SYMLIN and how to inject SYMLIN the right way before you inject it for the first time. Use a new needle for each SYMLIN injection. Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them. This SymlinPen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of this SymlinPen. Check SYMLIN before you use it. SYMLIN should be clear and colorless. Do not use SYMLIN if the liquid looks cloudy or colored or has lumps or particles in it. Your SymlinPen may look empty because SYMLIN is a clear and colorless liquid. Small bubbles will not hurt you or affect your dose of SYMLIN. Do not transfer SYMLIN from your SymlinPen into a syringe. Do not inject your dose of SYMLIN if you: have low blood sugar (hypoglycemia) do not plan to eat. Do not inject SYMLIN if you skip a meal. Wait until the next meal and take your usual dose of SYMLIN at that meal. plan to eat a meal with less than 250 calories or 30 grams of carbohydrate are sick and cannot eat your usual meal are having surgery or a medical test where you cannot eat If you take more than your prescribed dose of SYMLIN, you may get nauseous or vomit, and may not be able to eat the amount of food you usually eat. If you take more SYMLIN than your prescribed dose, pay careful attention to the amount of insulin you use because you may be at more risk for low blood sugar. Contact your healthcare provider for guidance. Supplies you will need to give each injection of SYMLIN: SymlinPen 120 Pen-Injector (Pen) (See Figure A) a new SymlinPen compatible needle (See Figure B). Pen needles are not included. Use 29, 30, or 31 gauge disposable pen needles. Ask your healthcare provider which needle gauge and length is best for you. alcohol swab 1 sharps container for throwing away used SymlinPens and needles. See Disposing of used SymlinPens and needles at the end of these Instructions for Use. Pen Cap Covers Pen when not in use Pen Parts Pen Label EXP date on back Dial Turn to dial dose Knob: Pull out to load dose. Spin to check dose. Push to inject dose. Cartridge Clear colorless liquid (Figure A) Window Shows dialed dose Dose Check Look for line, arrow, and number Attach Pen Needle (needles not included) Remove paper tab from outer needle cover. Push needle straight onto Pen. Screw needle on until tight. Remove outer needle cover and save for needle removal. Remove inner needle cover and throw away. Inner Needle Cover Paper Tab (Figure B) Outer Needle Cover Needle
Preparing your SymlinPen: Wash your hands with soap and water. Check the SymlinPen label before each use to make sure you have the right SymlinPen. Check the expiration date (EXP) on the SymlinPen label (See Figure A). Do not use the SymlinPen past the expiration date printed on the label. Check the liquid in your SymlinPen to make sure you have enough SYMLIN left in your SymlinPen to load your correct dose. The lines on the cartridge show about how much SYMLIN is left in your SymlinPen. When the top of the plunger is at the thickest line on the cartridge, your SymlinPen is almost empty (See Figure C). (Figure C) Attaching a Needle: Step 1: Pull the pen cap straight off the SymlinPen and wipe the rubber seal with an alcohol swab. Figure D Step 2: Get a new needle Peel off the paper tab and throw it away. Figure E Step 3: Push the capped needle straight onto the end of the SymlinPen and twist the needle clockwise until it is tight. Figure F
Step 4: Pull off the outer needle cover. Do not throw it away. Pull off the inner needle cover and throw it away. Figure G New Pen Setup - Priming your SymlinPen: Note: Steps 5 through 7 are only required if you are using your SymlinPen for the first time. Do not repeat Step 1 through 4 before each dose. If you have already primed your SymlinPen, go to Step 8 for instructions about giving your scheduled dose. Step 5: Turn the dial to select 60 mcg. You should see the number 60 in the window. Figure H Step 6: Pull the knob straight out as far as it will go. You should hear a clicking sound while you are pulling the knob out. Figure I Step 7: Hold your SymlinPen with the needle pointing up. Push the knob all the way in until it stops. You should hear a clicking sound while you are pushing the knob in. A stream of liquid should be seen from the needle. If you do not see a stream of liquid, repeat Step 6 and Step 7 (you may repeat up to 3 times). If you still do not see a stream of liquid after 3 attempts, change the needle and repeat Step 6 and Step 7. If you still do not see a stream of liquid, call Information Support. Figure J
Selecting your routine dose: Step 8: Turn the dial to select the correct dose you need to inject. Figure K Step 9: Pull the knob straight out as far as it will go. You should hear a clicking sound while you are pulling the knob out. Figure L Step 10: Turn the knob forward or backward until you see the correct dose you need to inject. Check that you see the line to make sure you have loaded your full dose. You should see a line, arrow, and the number of your dose. If you do not see a line, arrow, and the number of your dose, do not inject the dose. Point the needle away from you, push the knob all the way in until it stops, then repeat Step 8 to Step 10. Once the knob has been pulled out, the dial will not move and you cannot reset your dose. If correct dose was not selected, push in the knob to discard the dose and repeat the instructions. If the knob is pushed in all the way, and you cannot turn the dial, call Information Support. Figure M Figure N Giving your SYMLIN injection: Inject your SYMLIN exactly as your doctor has shown you. Change (rotate) injection sites for SYMLIN. Inject SYMLIN at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN and insulin in the same site. To help reduce the chances of getting a reaction at the injection site, let SYMLIN come to room temperature before you inject it.
Step 11: Choose your injection site. SYMLIN is injected under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose. Step 12: Insert the needle into your skin. Figure O Figure P
SYMLIN (pramlintide acetate) injection for subcutaneous use 5 Step 13: Put your thumb on the knob and push the knob all the way in until it stops. You should hear the clicking as you push and hold the knob in and slowly count to 10 to give your full dose. Figure Q Step 14: Pull the needle out of your skin. If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area. A drop or 2 of liquid on the needle tip is normal. It will not affect your dose. If you see more than 2 drops, you may not have received your full dose. Do not inject another dose. Talk to your doctor for help. Figure R Step 15: Carefully replace the outer needle cover by pushing straight onto the end of the SymlinPen. Figure S Step 16: Unscrew the capped needle counterclockwise with the outer needle cover on it and throw it away. Do not store the SymlinPen with the needle attached or with the knob pulled out to prevent air bubbles. Step 17: Replace the pen cap. Figure T Figure U
After your injection: Put your used needles and SymlinPen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: æ made of a heavy-duty plastic, æ can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, æ upright and stable during use, æ leak-resistant, and æ properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and SymlinPen. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA s website at: http://www.fda.gov/safesharpsdisposal Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. How should I store my SymlinPen? Unused SymlinPens: Keep SYMLIN in the refrigerator between 36F to 46F (2C to 8C), until you are ready to use it. Do not freeze. Do not use SYMLIN if it has been frozen. Keep unopened SYMLIN out of the light. Used SymlinPens: Store SymlinPens in the refrigerator or at room temperature between 36F to 86F (2C to 30C) for up to 30 days. Throw away used SymlinPens after 30 days of use, even if a used SymlinPen still has medicine in it. Do not use SymlinPens (opened or unopened) after the expiration (EXP) date printed on the carton and the label. General information about the safe and effective use of SymlinPens. If you drop your SymlinPen, you should prime it before you use it to make sure your SymlinPen works. Do not use your SymlinPen if any part looks broken or damaged. Keep SYMLIN and all medicines out of the reach of children. It is not known if SYMLIN is safe and effective in children. If you are having problems using your SymlinPen, go to www.symlin.com or call Information Support at 1-800-236-9933. These Instructions for Use have been approved by the U.S. Food and Drug Administration. SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group of companies. Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Revised: March 2015 US-9066 5/17